Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT00193037|
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : July 19, 2013
Last Update Posted : July 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Liposomal Doxorubicin Drug: Docetaxel||Phase 2|
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:
- Liposomal Doxorubicin
For ever 2 patients treated, 1 will receive treatment A (Liposomal Doxorubicin) and 1 will receive treatment B (Docetaxel). Patients demonstrating progression on either ARM will be eligible for cross over to treatment in the other ARM, provided patient still meets the eligibility laboratory and performance status criteria. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized Crossover Study Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer|
|Study Start Date :||February 2001|
|Primary Completion Date :||December 2008|
|Study Completion Date :||November 2009|
Experimental: Liposomal Doxorubicin
Liposomal doxorubicin 40 mg/m2 by 1 hour IV infusion repeated every 28 days.
Drug: Liposomal Doxorubicin
Other Name: Doxil
Weekly docetaxel 36 mg/m2 by 30 minute IV infusion on days 1, 8, and 15 of the 28 day cycle
Other Name: Taxotere
- Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 Months ]ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.
- Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. [ Time Frame: 18 Months ]PFS was defined as the interval from first study treatment until the date that the first progression of breast cancer was documented, or death occurred.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193037
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Denise A. Yardley, MD||SCRI Development Innovations, LLC|